BEUDAMED
    FDA Adverse Event Death Summary report: N

    AIGIS-R MEDIUM

    MDR report key: 5643203 · Received May 10, 2016

    Report

    Report Number
    3005619263-2016-00017
    Event Type
    Death
    Date Received
    May 10, 2016
    Date of Event
    October 1, 2015
    Report Date
    April 12, 2016
    Manufacturer
    TYRX, INC.
    Product Code
    FTL
    PMA / PMN Number
    K130943
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON AN ABSTRACT/POSSIBLE FUTURE JOURNAL LITERATURE. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. MULTIPLE PATIENTS WERE REFERENCED IN THE ARTICLE. THE BASELINE CHARACTERISTICS OF THE PATIENTS REFERENCED IN THE ARTICLE IS GENDER/AGE IS MALE/(B)(6). THERE IS NO INDICATION AS TO THE MANUFACTURER OF THE CARDIAC IMPLANTABLE ELECTRONIC DEVICES (CIEDS). WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. REFERENCED ABSTRACT/ARTICLE WHICH WAS PRESENTED (B)(6) 2015 AT THE IDWEEK PRESS CONFERENCES: ¿USE OF ANTIBACTERIAL ENVELOPE TO REDUCE CARDIAC IMPLANTABLE ELECTRONIC DEVICE (CIED) INFECTIONS.¿ NO FURTHER CITATION INFORMATION WAS AVAILABLE. REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING CARDIAC IMPLANTABLE ELECTRONIC DEVICE (CIED) AND INFECTIONS WHILE USING AN ANTIBACTERIAL ENVELOPE. MULTIPLE PATIENTS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE DEVICE SERIAL NUMBERS. THE ARTICLE INDICATED THAT THERE WERE TWO PATIENT DEATHS AS A RESULT OF CIED INFECTIONS WHILE USING THE ENVELOPE. OF NOTE, THE INFORMATION DOES NOT SUGGEST THAT THE DEATHS WERE RELATED TO NEITHER THE CIED NOR THE ENVELOPE. FURTHER FOLLOW UP DID NOT YET YIELD ANY ADDITIONAL INFORMATION AND ANY ADDITIONAL INFORMATION PERTAINING TO THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT YET RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299707 AIGIS-R MEDIUM MESH, SURGICAL, POLYMERIC FTL TYRX, INC. CMRM6122US-S

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death| H| R CARDIAC IMPLANTABLE ELECTRONIC DEVICE